Subjects with histologically confirmed metastatic and / or unresectable GIST

At least imatinib and sunitinib as prior treatment regimens with progression on or intolerance to imatinib and sunitinib

Adequate bone marrow, liver and renal function

Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve adequate birth control. Adequate contraception is defined in the study as any medically recommend method (or combination of methods) as per standard of care.

Exclusion Criteria:

Prior treatment with regorafenib

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting study drug

Pregnant or breast-feeding subjects. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of study drug.

Concomitant participation or participation in another therapeutic trial with investigational new drugs within 30 days or 5 drug half-lives (if drug half life in subjects is known), whichever is shorter

If any other approved tyrosine kinase inhibitor was given within 1 week or a minimum of 5 drug half-lives whichever is longer (i.e. within 7 days for imatinib, or within 10 days for sunitinib)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646593